Last reviewed · How we verify
Bacille Calmette-Guérin (BCG)
BCG is a live attenuated mycobacterial vaccine that stimulates innate and adaptive immune responses to enhance anti-tumor immunity and treat bladder cancer.
BCG is a live attenuated mycobacterial vaccine that stimulates innate and adaptive immune responses to enhance anti-tumor immunity and treat bladder cancer. Used for Non-muscle invasive bladder cancer (NMIBC), high-grade or recurrent, Bladder cancer prophylaxis after transurethral resection.
At a glance
| Generic name | Bacille Calmette-Guérin (BCG) |
|---|---|
| Also known as | BCG-Vaccin SSI [Statens Serum Institut], Danish strain 1331 |
| Sponsor | TASK Applied Science |
| Drug class | Live attenuated vaccine / Immunotherapy |
| Target | Pattern recognition receptors (TLR2, TLR4, NOD2); non-specific immune activation |
| Modality | Biologic |
| Therapeutic area | Oncology / Immunology |
| Phase | FDA-approved |
Mechanism of action
BCG works by activating dendritic cells, macrophages, and T cells through pattern recognition receptors, triggering a robust Th1-mediated immune response. When instilled directly into the bladder, it promotes local and systemic anti-tumor immunity, leading to destruction of urothelial cancer cells and prevention of recurrence. The mechanism also involves non-specific immune activation and direct cytotoxic effects on cancer cells.
Approved indications
- Non-muscle invasive bladder cancer (NMIBC), high-grade or recurrent
- Bladder cancer prophylaxis after transurethral resection
Common side effects
- Dysuria
- Urinary frequency
- Hematuria
- Fever
- Malaise
- BCG sepsis (rare)
Key clinical trials
- A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer (PHASE2)
- Melbourne Infant Study - Bacille Calmette Guérin (BCG) for Allergy & Infection Reduction (PHASE3)
- Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS) (PHASE2)
- BCG Vaccination to Protect Healthcare Workers Against COVID-19 (PHASE3)
- Avelumab Plus Bacille Calmette-Guerin (BCG) in Patients With Non-muscle Invasive Bladder Cancer (PHASE1, PHASE2)
- A Controlled Human Infection Model (CHIM) With Intradermal BCG in Malawi (NA)
- BCG Revaccination in Children and Adolescents (PHASE3)
- Using BCG Vaccine to Understand Tuberculosis Infection (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Bacille Calmette-Guérin (BCG) CI brief — competitive landscape report
- Bacille Calmette-Guérin (BCG) updates RSS · CI watch RSS
- TASK Applied Science portfolio CI